Bright Light Therapy in Seasonal Affective Disorder (SAD)

University of Oulu

Status: Completed

Conditions: Seasonal Affective Disorder

Treatments: Other: Transcranial Brain-Targeted Bright Light Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01293409

FI (FWA00000190) 11/2008b

Details and patient eligibility

About

Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)

The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20

• The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20

• The 21-item Hamilton Depression Rating Scale score ≥ 10

• The 8-item atypical symptom score ≥ 5

  • patient is over 18 years
  • patient can read and understand the subject information sheet
  • patient has signed the informed consent form
  • patient is not pregnant

Exclusion criteria

• patient has a lifetime psychotic disorder
• patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
• patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
• patient has alcohol or some other substance use dependence or misuse
• patients has some unstable somatic disorder
• patient uses some psychotropic agencies
• patient is, in the opinion of the investigator, unsuitable for any reason
• patient is a member of the site personnel or their immediate families
• patient has had bright light therapy via ear canals during the current episode

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The amount of photic energy of light is considered to be non-therapeutical

Treatment:

Other: Transcranial Brain-Targeted Bright Light Treatment

Intermediate dose

Experimental group

Description:

The amount of photic energy of bright light is considered to be "intermediate"

Treatment:

Other: Transcranial Brain-Targeted Bright Light Treatment

High dose bright light

Experimental group

Description:

The amount of photic energy of bright light is considered to be fully therapeutic

Treatment:

Other: Transcranial Brain-Targeted Bright Light Treatment